9Line— 510(k) K211941
Substantially EquivalentEnergetic Designs, Inc.
FDA 510(k) clearance K211941 for 9Line, Substantially Equivalent on 2022-01-27. Applicant: Energetic Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Energetic Designs, Inc.
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Broomfield, CO, US
Recent devices under product code DSA
view all- K254114 — Baylis Connector Cable
- K252827 — IBP cable Becton Dickinson (2606488) +5 more
- K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m +8 more
- K242986 — SpO2 Extension Cable
- K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC +9 more
Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.